Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis:a Multicenter Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Fibrosis
- Sponsor
- China-Japan Friendship Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- the diagnostic performance of transbronchial cryobiopsy(TBLC)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy(TBLC)in progressive pulmonary fibrosis. The main question it aims to answer are: • Determine the prognosis, health economics, and therapeutic strategy changes of patients with TBLC retrograde malleable pulmonary fibrosis. Participants will be randomly divided into two groups, and received TBLB or TBLC.
Investigators
Gang Hou
Principal Investigator
China-Japan Friendship Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.
Exclusion Criteria
- •Patients with platelet counts below 50,000×109/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC
Outcomes
Primary Outcomes
the diagnostic performance of transbronchial cryobiopsy(TBLC)
Time Frame: 1 month after transbronchial cryobiopsy
the sensitivity and specificity of transbronchial cryobiopsy(TBLC)in suspected progressive pulmonary fibrosis
Secondary Outcomes
- the safety of transbronchial cryobiopsy(TBLC)(7 days and 1 month after transbronchial cryobiopsy)